integrating strategies for prevention of preeclampsia and anemia in pregnancy into primary ...

113 Pages·2016·1.12 MB·English

INTEGRATING STRATEGIES FOR PREVENTION OF
PREECLAMPSIA AND ANEMIA IN PREGNANCY INTO
PRIMARY HEALTHCARE DELIVERY IN KENYA
A Dissertation
Presented to the Faculty of the Graduate School
of Cornell University
in Partial Fulfillment of the Requirements for the Degree of
Doctor of Philosophy

by

Moshood Olanrewaju Omotayo
August 2016

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©2016 Moshood Olanrewaju Omotayo

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INTEGRATING STRATEGIES FOR PREVENTION OF PREECLAMPSIA AND ANEMIA IN PREGNANCY INTO
PRIMARY HEALTHCARE DELIVERY IN KENYA
Moshood .O. Omotayo, Ph.D.
Cornell University, 2016.
BACKGROUND: Hypertensive disorders in pregnancy are major contributing factors to maternal and
perinatal mortality globally. The World Health Organization has issued guidelines on calcium
supplementation in pregnancy to prevent these conditions, but there is limited guidance on how to
translate the WHO guidelines into public health impact, especially in conjunction with iron-folic acid
(IFA) supplementation. The over-arching objective of this dissertation was to investigate key issues that
would influence translation into public health impact, through primary care facilities in rural Kenya.
METHODS: With the trials of improved practices (TIPs) approach, we studied acceptability of the
guidelines among 38 pregnant women in 6 community groups in western Kenya. We assigned
participants to 3 dosage regimens, representing potential trade-offs between bioavailability and
acceptability. Participants selected either of two Ca products with different organoleptic properties.
They were provided with supplements, counseled on the guidelines, and interviewed 4 times over 6
weeks to assess barriers and facilitators. Building on findings from this formative research, we used a
program impact pathway (PIP) model to guide the design and evaluation of integrated Ca and iron-folate
supplementation in Kakamega county in western Kenya. We embedded a cluster-randomized trial in the
district-wide program, to examine the impact of regimen complexity on adherence and supplement
consumption. We provided healthcare workers with job aids, trained them on counseling techniques
and supplementation guidelines, and developed behavior change materials (calendars) for pregnant
women. We randomly allocated health facilities to prescribe either 1.0 or 1.5 g / d Ca, along with
standard IFA. We collected data from 16 health facilities and 990 pregnant women between 16-30
weeks gestational age, through facility spot-checks and client exit interviews, including amount of Ca
supplement consumed (mg/d), measured by pill counts assessed at 4wks and 8wks after recruitment.
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RESULTS: In the TIPs, all participants were willing and actually tried consuming the supplements.
Participants preferred the ‘sweet taste’ of the chewable product and liked the ability to consume it
without water. Difficulties with the complex regimen included afternoon doses when women were likely
to forget, and having to wait hours after supper for last dose. Daily tracking of consumption with a
calendar, keeping supplements in conspicuous locations and requesting support from relatives were
identified as strategies that supported adherence. In the PIP analysis, supplements and job aids were
available during 90% of facility spot-check episodes; calendar availability was lower (78%). Most clients
(91%) during 1st ANC visits had calendars at exit interviews, and over 80% reported being counseled with
counseling guides. Over 98% of clients received Ca and IFA supplements, but only 76% received enough
Ca supplements to last until return date. In the intention-to-treat analysis with regimen as fixed effect
and healthcare facility and participant identifiers as random effects in a mixed effects model, pregnant
women in facilities with 1.5 g/d prescription consumed an average of 388 mg/d (95% CI 341, 434) more
supplemental Ca than those in facilities with 1.0 g/d prescription.
CONCLUSIONS: Pregnant women are likely to adopt Ca supplementation, with appropriate
programmatic adaptations. Careful attention to product attributes, regimen complexity and strategies
for reassuring and reminding women is needed to adapt the WHO guidelines to context. The district-
wide implementation illustrates a feasible approach to integrating Ca supplementation with prenatal IFA
supplementation in primary healthcare delivery, guided by a comprehensive program model. Policy
makers and program planners should pay careful attention to supply chain, healthcare worker
dispensing behaviour and appropriateness of regimen for their setting. Recommending a lower and
simpler 2-dose regimen led to lower calcium intake in Kenya, and therefore might be less effective than
the current WHO recommendations.

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BIOGRAPHICAL SKETCH
Moshood Omotayo graduated with the medical degree from the Lagos State University College of
Medicine, where he was president of the student body. He earned a Master in Public Health degree,
concentrating in Global Health and Infectious Diseases Epidemiology at the Harvard School of Public
Health, before completing his PhD at Cornell University. He worked as a house officer at Lagos Island
Maternity and Massey Children Hospitals, the busiest maternal and pediatric care centers in Nigeria,
before serving as medical officer and practice manager for a family medicine practice in sub-urban

Lagos, Nigeria.

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ACKNOWLEDGMENTS
All praise is due to the almighty. I thank the Oke and Omotayo families for their unconditional support
and love through the years of this project. I thank my sweetheart, Fausat Bimbo Oke, for her tolerance
and support in the last 4 years. I thank Dr. Katherine Dickin, for her support as principal investigator on
the MICa grant that supported most of this work. I thank Rebecca Stoltzfus, for inviting me to this
project, but more importantly for her support as academic advisor and unwavering confidence in my
potential. David Pelletier, Kimberly O’Brien and Patricia Cassano have been truly special and particularly
generous as thesis committee members, in providing academic, social and professional guidance and
support during my studies. Francoise Vermeylen and her team at the Cornell Statistical Consulting unit
provided the statistical support and training that I needed for this project. Several members of the
Cornell faculty and staff, besides my special committee, provided me with much training and support
through different activities, including crucial coursework and presentations: Kathleen Rasmussen,
Beverly Gedvillas, Saurabh Mehta, Sera Young, Maureen Waller, Zhenglong Gu, Robert Parker, Charles
McCormick and Parfait Eloundou-Enyegue were tremendously helpful among others. The CENTIR
research group and MICa project team consistently provided intellectual stimulation and social support.
I thank my friends and colleagues from my medical school days, during my MPH studies and here in
Ithaca, too numerous to list here, but whose collective support, friendship and goodwill have continued
to inspire me. Collaborators in Kenya, including Erick Mwanga and Jessica Otieno of the Kakamega North
sub-county health management team, Peter Ofware of AMREF Health Africa in Kenya, Professor Zahida
Qureshi of the University of Nairobi, Crispin Ndedda, Charmaine Kinuthia, Dr Jacqueline Kung’u and
Chris Wanyoike, all of the Micronutrient Initiative in Kenya, provided immense support for this project. I
remain grateful to Felix Makasanda, Rose Chesoli, Erina Oundo, Pamela Murambi, Hillary Opoma, Brian
Kitiavi, Clinton Ochieng, Mercy Siakeni, Steve Amolo, and Ali Tumo, members of my field team in Kenya.
Belina Shisia, Bibianne Situma, Stephen Kamau, Benard Mageto, Lucy Natecho, Jane Anyango, Andrew
Nyongesa, Anne Khaemba, Beatrice Ocholla, Samuel Okoth, Stephen Mwangi and Herbert Barasa, all
provided professional and social support during my stay in Kenya. Lastly and most importantly, I remain
grateful to the people of Kakamega county for their hospitality and participation in this study. This work
was mainly funded by the Micronutrient Initiative. I also received financial support from Cornell
University Division of Nutritional Sciences and the Lewis and Esta Ress Fellowship.

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TABLE OF CONTENTS
Title page…………………………………………………………………………………………………………………………………..1
Biographical Sketch…………………………………………………………………………………………………………………...5
Acknowledgements…………………………………………………………………………………………………………………..6
Introduction and Background……………………………………………………………………………………………………8
Chapter 2…………………………………………………………………………………………………………………………………27
Chapter 3…………………………………………………………………………………………………………………………………51
Chapter 4…………………………………………………………………………………………………………………………………77
Conclusion…………………………………………………………………………………………………………………………….…98
References…………………………………………………………………………………………………………………………….104

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CHAPTER ONE
INTRODUCTION & BACKGROUND

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Introduction
The primary challenge in improving global maternal, neonatal and child health is the sustainable and
effective delivery of high impact interventions for pregnant women and nursing mothers at scale. Public
health programs fail to achieve impact due to two main reasons: a) lack of validity of the program
theory; and b) inadequate implementation of core activities in the program model 1.
Ante-natal nutrition in developing countries has had limited programmatic success, 2 and integration of
new programs into existing platforms will benefit from comprehensive and detailed theory-based
programming and evaluation. Preeclampsia/eclampsia remains a major contributor to maternal and
perinatal morbidity and mortality globally3–5 . Systematic reviews of randomized controlled efficacy trials
confirm that Calcium (Ca) supplementation significantly lowers the risk of preeclampsia6,7. The World
Health Organization (WHO) recommends Ca supplementation in populations with low habitual intake as
part of antenatal care (ANC) programs, to prevent preeclampsia 8.Integrating calcium supplementation
into existing ante-natal programs will likely benefit from a comprehensive approach to avoid
implementation failure, given the challenges faced by existing ante-natal iron supplementation
programs. Increased risk of maternal and child morbidity and mortality due to severe anemia, impaired
physical and neuropsychological development due to iron deficiency and limitations of iron
supplementation programs are well known.
As reproductive health and nutrition programs seek to integrate the WHO guidelines on calcium
supplementation for prevention of preeclampsia with existing ante-natal care platforms, further
research is warranted to clarify issues related to not only minimum effective dose, timing of initiation,
and mode of administration of prenatal supplements but research to also understand barriers and
factors that will influence acceptability, adherence, and feasibility of full scale implementation is
needed. This dissertation addresses key components of this research gap.
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The overall objective of this work is to provide insight into issues that will influence success in large-scale
implementation. I examine development, implementation and evaluation of primary healthcare and
micronutrient interventions, aimed at primary prevention of preeclampsia and anemia among pregnant
women in rural Kenya. Chapter one provides an introduction and background to key issues related to
integration of strategies for primary prevention of preeclampsia and anemia into ante-natal care
delivery in resource-limited settings. Chapter two reports rationale, design, analysis, results and
conclusion of a trials of improved practices study, examining socio-cultural factors influencing adoption
and acceptability of calcium and iron supplementation among pregnant women in rural western Kenya.
Chapter three examines design, implementation and evaluation of a district-wide program aimed at
integrating strategies for primary prevention of preeclampsia and anemia into primary healthcare
delivery, guided by the program impact pathway approach. Chapter 4 describes the design, analyses,
results and conclusions of a cluster-randomized non-inferiority comparison of the WHO regimen and an
alternative regimen, with supplement consumption and adherence as primary outcomes. Taken
together, these studies advance knowledge regarding design, implementation and evaluation of policies
and programs to integrate primary prevention of preeclampsia and anemia in pregnancy into existing
ante-natal care platforms in resource-limited settings in Africa. They also provide a model for the
development of programs for integrating primary prevention of preeclampsia into existing ante-natal
care platforms.

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